Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19259 |
| Brand Name: | Roche Virtuoso software |
| Model: | 07299303001 (V5.4), 07072984001 (V5.5) |
| Affected: | |
| Software version: | 5.4 and 5.5 |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Issue: | The iScan Coreo or VENTANA iScan HT scans slides at 4x, 10x, 20x, or 40x magnifications. For images scanned at 4x, 10x, and 40x magnification in v5.4 and v5.5, the linear and area measurement tools display a value that is 1/5, 1/2 and 2x the actual measurement, respectively. The measurement will be displayed incorrectly regardless of what magnification the image is viewed at. Customers who have used the measurement tool for slides that were scanned at 4x, 10x, or 40x to assist with a diagnosis, need to be aware that an incorrect estimation of clinical stage could lead to improper treatment. For images that are scanned at 20x magnification, the measurement tools work properly in all versions of Virtuoso including versions 5.4 and 5.5. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/10/2015 |
